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EXHIBIT 1.8
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
AMENDED AND RESTATED LICENSE AGREEMENT
--------------------------------------
This is an Amended and Restated License Agreement dated as of September 3, 1999
(the "Amended Agreement") constituting an amendment and restatement of the
License Agreement made as of the 24th day of November, 1995 (the "Original
Agreement").
BETWEEN:
BIOMIRA INC., a corporation having
its principal office at Edmonton, Alberta,
(hereinafter called "Biomira")
OF THE FIRST PART;
ALTAREX CORP. (formerly AltaRex Inc.),
a corporation having its principal
office at Edmonton, Alberta, (hereinafter
called "AltaRex")
OF THE SECOND PART;
WHEREAS Biomira has certain rights with respect to the murine working hybridoma
cell bank B43.13 and the murine antibody MAb B43.13 which are the subject of
this Agreement and certain experimental and clinical data related thereto;
WHEREAS AltaRex wishes to obtain from Biomira and Biomira is willing to grant to
AltaRex an exclusive worldwide license for the use of such murine working
hybridoma cell bank and murine antibody MAb B43.13 solely for Anti-Idiotype
Applications (as defined below), as well as for the use of such experimental and
clinical data for Anti-Idiotype Applications, upon the terms and subject to the
conditions set forth in this Agreement;
WHEREAS Biomira and AltaRex entered into the Original Agreement for the
foregoing purposes and have determined that it is in their mutual best interests
to amend and restate the Original Agreement;
NOW THEREFORE in consideration of the covenants, terms and conditions set forth
in this Amended Agreement and other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the parties agree that this
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Amended Agreement shall supersede in its entirety the Original Agreement and
that the Amended Agreement shall read as follows:
ARTICLE I
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DEFINITIONS
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1.1 Definitions
In this Agreement, unless otherwise provided, the following terms shall
have the following meanings:
(1) "AFFILIATE" has the meaning ascribed to that term in the Canada Business
Corporations Act (Canada);
(2) "AGREEMENT" means this amended and restated license agreement, together
with any further amendments to or restatements of this amended and restated
license agreement;
(3) "ALTAREX INFORMATION" means all information of a confidential nature of
AltaRex or any of its Affiliates including, without limiting the generality
of the foregoing, all biological material, plant, animal and human
laboratory and clinical data, technical information, Know-How, inventions,
techniques, processes, systems, formulae, results of experimentation,
designs, statistics and records;
(4) "ANTI-IDIOTYPE APPLICATIONS" means the induction of anti-idiotype and/or
cellular immune response by administration of a formulation containing an
antibody, antibody fragment or antibody derivative for the treatment or
prevention of disease. Without limiting the generality of the foregoing,
Anti-Idiotype Applications specifically includes the administration of the
B43 Antibody for therapeutic or prophylactic purposes;
(5) "B43 ANTIBODY" means the murine antibody MAb B43.13;
(6) "B43 WORKING CELL BANK" means Biomira's murine working hybridoma cell bank
B43.13 of the murine hybridoma clone B43.13 such cell bank being produced
at the Charles River Laboratories and used in the OVAREX(TM) program as of
November 24, 1995 (the effective date of the Original Agreement);
(7) "BIOMIRA INFORMATION" means all information of a confidential nature of
Biomira or any of its Affiliates including, without limiting the generality
of the foregoing, all Biomira Technology, biological material, plant,
animal and human, laboratory and clinical data, technical information,
Know-How inventions, techniques, processes, systems, formulae, results of
experimentation, designs, statistics and records;
(8) "BIOMIRA TECHNOLOGY" means all Know-How, technical expertise, information,
inventions and discoveries, whether patentable or not, and all copyrights,
patents, trademarks, industrial designs, and other intellectual property
rights or benefits made, authored, conceived, created, compiled or
developed by or for, or acquired by Biomira or any of its Affiliates;
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(9) "CONFIDENTIAL INFORMATION" means any and all Biomira Information or AltaRex
Information, as the case may be, and any and all information of a
confidential nature relating to Biomira, AltaRex, the relationship among
the parties to this Agreement and the terms and subject matter of this
Agreement;
(10) "DATA" means, as of November 24, 1995 (the effective date of the Original
Agreement), the experimental and clinical data and records of Biomira or
Biomira Research, Inc. relating to the B43 Antibody, the B43 Working Cell
Bank and the product OVAREX(TM) owned by Biomira or Biomira Research, Inc.;
(11) "EFFECTIVE DATE" means December 1, 1995;
(12) "FIRST COMMERCIAL SALE" means, on a country-by-country basis, the first
commercial sale of a Licensed Product in a country, excluding sales for
clinical trial purposes;
(13) "IPT" means the use of an antibody to target a photodynamic effector
molecule to a cell whereby the effector molecule kills the cell;
(14) "IRT" means the use of an antibody to target a radioactive effector
molecule to a cell whereby the effector molecule kills the cell;
(15) "KNOW-HOW" means, with respect to AltaRex or Biomira as the case may be,
all technical information, expertise, Know-How and information including
without limitation all data, results of experiments, formulae,
specifications, procedures, tests, compounds, cell lines, cultures,
constructs, effectors, development strains, micro-organisms, assay systems,
assay protocol and assay supporting material, fermentation and purification
material and techniques;
(16) "LICENSED PRODUCT" means any product (including without limitation
OVAREX(TM)) based, in whole or in part, on the Technology (which defined
term, for purposes of this definition, shall include the B43 Antibody and
any derivative thereof);
(17) "MULTI-EPITOPIC PATENT RIGHTS" means International Application
PCT/IB96/00461 and any national stage application claiming priority
thereof, and any continuations, divisionals, continuations-in-part thereof,
and any foreign equivalents, and any patents issuing therefrom, including
any reissues thereof;
(18) "NET SALES REVENUE" means the aggregate of the gross amounts received from
all sales, uses or other dispositions of Licensed Products by AltaRex or
any Sublicensee after deducting (i) customary trade, cash and quantity
discounts actually allowed and taken, (ii) tariffs, duties, excises, sales
tax or other taxes imposed upon and paid with respect to the production,
sale, delivery or use of any product (excluding income-based taxes), and
(iii) amounts actually paid or credited to unrelated purchasers in
accordance with normal commercial practice by reason of (A) rejections,
defects, recalls or returns, or (B) chargebacks, refunds, rebates or
retroactive price reductions, and then crediting any refund of taxes
deducted (all as determined in accordance with Canadian generally accepted
accounting principles applied on a consistent basis). In the event a
Licensed Product is sold as part of a Combination Product (as defined
below), the Net Sales
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Revenue from the Combination Product, for the purposes of determining
royalty payments, shall be determined by multiplying the Net Sales Revenue
of the Combination Product (as defined in the foregoing Net Sales Revenue
definition), during the applicable royalty reporting period, by the
fraction, A/A+B, where A is the average sale price of the Licensed Product
when sold separately in finished form in the country in which the
Combination Product is sold and B is the average sale price of the other
pharmaceutical product(s) included in the Combination Product when sold
separately in finished form in the country in which the Combination Product
is sold, in each case during the applicable royalty reporting period or, if
sales of both the Licensed Product and the other pharmaceutical product(s)
did not occur in such period, then in the most recent royalty reporting
period in which sales of both occurred. In the event that such average sale
price cannot be determined for both the Licensed Product and all other
pharmaceutical products(s) included in the Combination Product, Net Sales
Revenue for the purposes of determining royalty payments shall be
calculated by multiplying the Net Sales Revenue of the Combination Product
by the fraction of C/C+D where C is the fair market value of the Licensed
Product in the country in which the Combination Product is sold and D is
the fair market value of all other pharmaceutical product(s) included in
the Combination Product in the country in which the Combination Product is
sold. In such event, AltaRex shall in good faith make a determination of
the respective fair market values of the Licensed Product and all other
pharmaceutical products included in the Combination Product, and shall
notify Biomira of such determination and provide Biomira with data to
support such determination. Biomira shall have the right to review such
determination and supporting data, and to notify AltaRex if it disagrees
with such determination. If Biomira does not agree with such determination,
the parties shall attempt to reach agreement in good faith as to such
respective fair market values.
As used above, the term "Combination Product" means any product which
comprises the Licensed Product and other distinct pharmaceutical
products;
The sale or disposition of a Licensed Product by AltaRex to or among
its Sublicensees shall not be subject to royalties based upon Net
Sales Revenue, unless such Sublicensee is the end user of the Licensed
Product, but rather shall be calculated upon the sale or disposition
of a Licensed Product by any such Sublicensee to an independent third
party. If the Sublicensee is the end user of the Licensed Product and
the transaction with such Sublicensee is not an "arms' length"
transaction, then the "amount received" shall be the greater of (a)
the actual amount received, or (b) the amount which would have been
received had such sale or other disposition of the Licensed Product
been to a person at arms' length with the seller.
(19) "PATENT RIGHTS" means the patent applications referred to in EXHIBIT A to
this Agreement, together with all continuations, divisionals,
continuations-in-part, and any foreign equivalents, and any patents issuing
therefrom, including any reissues thereof, related to the Licensed Products
and Technology;
(20) "PROPRIETARY RIGHTS" means the Patent Rights and all copyrights,
trademarks, industrial designs and other intellectual property rights or
benefits (including Know-How)
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
specifically relating to Anti-Idiotype Applications of the B43 Antibody,
the B43 Working Cell Bank and the Data, in each case owned or controlled by
Biomira or Biomira Research, Inc., but excluding the Multi-Epitopic Patent
Rights;
(21) "ROYALTY PERIOD" means the period commencing on the Effective Date of the
Original Agreement and ending, on a country-by-country basis, on the latest
to occur of (i) [**] years after the first January 1 following the
First Commercial Sale of a Licensed Product in such country, or (ii) in
consideration of the compromise of claims between the parties relating to
the use of Biomira Data in the Multi-Epitopic Patent Rights application,
the date of expiration of the last patent included in the Multi-Epitopic
Patent Rights, if any, in such country;
(22) "SUBLICENSEE" means any person to whom AltaRex or any such person, directly
or indirectly, transfers any rights or privileges granted under this
Agreement, by sublicense or otherwise, to, among other things, enable such
person to make, use or sell Licensed Products;
(23) "TECHNOLOGY" means collectively the B43 Antibody, the B43 Working Cell
Bank, the Data and the Proprietary Rights as they relate to Anti-Idiotype
Applications.
1.2 NUMBER AND GENDER
Words importing the singular number only in this Agreement shall include
the plural number and vice versa and words importing one gender only in this
Agreement shall include all genders and words importing persons in this
Agreement shall include individuals, partnerships, corporations and any other
entities, legal or otherwise.
1.3 HEADINGS
The headings used in this Agreement are for ease of reference only and
shall not affect the meaning or the interpretation of this Agreement.
1.4 SCHEDULES
The schedules attached to this Agreement shall form part of this Agreement.
1.5 EFFECTIVE DATE
This Agreement shall commence as of the Effective Date.
ARTICLE II
GRANT OF RIGHTS
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2.1 GRANT OF RIGHTS
Subject to the terms. and conditions of this Agreement, Biomira hereby
grants to AltaRex and AltaRex hereby accepts (a) in consideration of the
up-front payment of $150,000 under
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Section 4.1 hereof, an exclusive worldwide right and license under the Patent
Rights, and (b) in consideration of the Net Sales Revenue Royalty under Section
4.2 hereof, an exclusive worldwide right and license under the Proprietary
Rights, exclusive of the Patent Rights, in either case (being (a) or (b) above)
to use the B43 Antibody, the B43 Working Cell Bank, and the Data to develop,
commercialize, manufacture, make, use and sell Licensed Products solely for
Anti-Idiotype Applications, including the right to grant sublicenses to third
parties, subject to the terms and conditions of this Agreement. AltaRex, on
behalf of itself and its
Affiliates, expressly agrees not to disclose or provide rights to any technology
of Biomira other than the Technology (and with respect to the Technology only
upon the terms set forth in this Agreement), or to make, or permit their
respective employees, agents or consultants to make, any statements with respect
to Biomira or any technology of Biomira other than the Technology (and with
respect to the Technology only as specifically authorized in this Agreement), or
other than with respect to information which is already fully in the public
domain through no fault of AltaRex or its Sublicensees. AltaRex shall, and shall
require each Sublicensee to, include in any sublicense agreement a provision
binding upon the Sublicensee that is substantially similar to the provisions of
this preceding sentence. Biomira on behalf of itself and its Affiliates,
expressly agrees not to permit their respective employees, agents or consultants
to make any statements with respect to AltaRex or any technology of AltaRex
other than as is specifically authorized under this Agreement or other than with
respect to information which is already fully in the public domain through no
fault of Biomira or its Affiliates or sublicensees. AltaRex shall promptly
notify Biomira in writing of any sublicense or other transfer of all or any of
the rights granted by Biomira under this Agreement and shall ensure that the
written commitment of each Sublicensee (as a term of the agreement with the
Sublicensee) is obtained to abide by all terms and conditions of this Agreement
applicable to such Sublicensee as a sublicensee, assignee or otherwise.
2.2 TERM
The term of the grant described in Section 2.1 of this Agreement shall
expire, on a country-by-country basis, on the latest to occur of (a) the
expiration of the Royalty Period, or (b) the expiration date of the last of the
Patent Rights included in the Proprietary Rights to expire in such country,
unless the parties mutually agree in writing to renew such term. Upon expiration
of the term of such grant, AltaRex shall have a worldwide, fully paid-up,
exclusive right and license under the Proprietary Rights to use the B43
Antibody, the B43 Working Cell Bank and the Data to develop, commercialize,
manufacture, make, use and sell Licensed Products solely for Anti-Idiotype
Applications, including the right to grant sublicenses to third parties upon the
terms and conditions set forth in this Agreement.
2.3 TERMINATION
(1) Any party to this Agreement shall have the right to terminate this
Agreement forthwith upon forty-five (45) days' prior written notice if the
other party defaults in the performance, observance or fulfillment of any
of its obligations under this Agreement. The termination shall become
effective at the end of the forty-five (45) day period unless the breaching
party cures such breach during such forty-five (45) day period.
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Notwithstanding the foregoing, in the event that AltaRex has prior to the
occurrence of such breach (i) granted to a financially sound third party a
license to manufacture, market or otherwise use the Technology and
Proprietary Rights and (ii) has designated such third party as the
designated licensee of AltaRex (the "Designated Licensee") by written
notice to Biomira setting forth, among other things, the name, address and
fax number of the Designated Licensee, Biomira shall also provide written
notice of default to the Designated Licensee at the address and/or fax
number provided to Biomira by AltaRex, and the Designated Licensee shall
have the right to cure such default within such forty-five (45) day period.
At any given time, AltaRex shall only be entitled to designate one (1)
Designated Licensee for purposes of this Agreement.
(2) Either party to this Agreement shall have the right to terminate this
Agreement forthwith upon written notice to the other party upon the
happening of any of the following events with respect to the other party:
(i) such party becomes bankrupt or insolvent;
(ii) such party ceases or threatens to cease to carry on business, or takes
or threatens to take any action to liquidate its assets or institutes
any proceedings under bankruptcy, reorganization, receivership,
insolvency or other similar laws affecting the rights of creditors
generally or the making by such party of a composition or an
assignment or trust mortgage for the benefit of creditors;
(iii) the liquidation, termination of existence or dissolution of such
party, or the voluntary appointment of a receiver, receiver-manager or
custodian for such party or any of its property; or
(iv) the institution against such party of any proceedings under any
bankruptcy, reorganization, receivership, insolvency or other similar
laws affecting the rights of creditors generally, which proceedings
are not dismissed within thirty (30) days of the date of filing
thereof, or any involuntary appointment of a receiver,
receiver-manager or custodian for such party or any of its property if
such appointment is not terminated or dismissed within thirty (30)
days thereof.
Notwithstanding the foregoing, AltaRex shall have the right during the five
(5) day period immediately following receipt of the default notice referred to
in this Section 2.3(2) to assign all of its rights and obligations under this
Agreement to the Designated Licensee and this Agreement shall remain in full
force and effect provided that the Designated Licensee is financially sound at
the time in question and agrees in writing, during such period, to be bound by
the terms of this Agreement in the place and stead of AltaRex and all defaults
hereunder are cured.
2.4 PROTECTING THE TECHNOLOGY
Biomira is not aware, as of November 24, 1995 (the effective date of the
Original Agreement), that the Technology infringes the rights of any third party
and agrees to use all reasonable efforts to protect the Technology during the
term of this Agreement. Except as required by law or any regulatory authority,
Biomira agrees not to knowingly provide, sell,
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
license, assign or supply the Technology for Anti-Idiotype Applications to any
person or entity that is not a party to this Agreement. AltaRex shall, and shall
cause each Sublicensee (by ensuring that the written commitment of the
Sublicensee is obtained as a term of the agreement granting the subject rights
to the Sublicensee) to, cooperate with and provide reasonable assistance to
Biomira in connection with protecting the Technology and other rights granted by
Biomira under this Agreement including, without limitation, in relation to
infringement actions against third parties.
2.5 MULTI-EPITOPIC PATENT RIGHTS.
(1) Biomira agrees, on behalf of itself and its Affiliates, to assign to
AltaRex, and hereby assigns to AltaRex, any claims of ownership it or its
Affiliates may have with respect to the Multi-Epitopic Patent Rights, this
being a continuing obligation that will be in effect during the term of
this Agreement. Biomira agrees that neither it nor any of its Affiliates
shall, directly or indirectly, challenge the rights of AltaRex to the
Multi-Epitopic Patent Rights. Biomira further agrees, on behalf of itself
and its Affiliates, to execute such further instruments and documentation
as may reasonably be requested by AltaRex to evidence the agreements set
forth in this subsection (a).
(2) AltaRex hereby grants to Biomira and its Affiliates a royalty-free,
perpetual, irrevocable, non-exclusive license, with the right to
sublicense, under the Multi-Epitopic Patent Rights to develop, make, use,
sell, import, or otherwise commercialize (1) antigen-based vaccine
products, other than an antibody, labeled for any cancer indication, (2)
idiotype vaccines labeled for hematological malignancies, and (3) vaccines
based upon [**] labeled for the treatment of Squamous cell carcinomas
(excluding all adenocarcinomas, such as (but not limited to) lung, stomach,
large and small bowel tumors, breast, ovarian, prostate and pancreatic
cancers).
(3) AltaRex hereby grants to Biomira and its Affiliates a royalty-bearing,
perpetual, irrevocable, non-exclusive license, with the right to
sublicense, under the Multi-Epitopic Patent Rights to develop, make, use,
sell, import, or otherwise commercialize products based upon [**] and
labeled for the treatment of adenocarcinoma, which would otherwise infringe
the Multi-Epitopic Patent Rights. The royalty rate shall be [**] % of Net
Sales Revenue of any product based upon [**] for which the manufacture, use
or sale would otherwise infringe the Multi-Epitopic Patent Rights. With
respect to the payment of such royalties, Biomira shall be subject to the
equivalent obligations as AltaRex under Sections 4.3 through 4.8 of this
Agreement.
2.6 IRT/IPT APPLICATIONS
The parties acknowledge that the use of IRT and IPT is not included within
the license set forth in Section 2.1. Biomira agrees neither to use (or permit
its Affiliates to use) nor to grant to any person or entity any rights or
licenses to use IRT or IPT in conjunction with Anti-Idiotype Applications.
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2.7 SUBLICENSE AGREEMENTS
(1) Within fifteen (15) days after AltaRex or any Sublicensee grants a
sublicense to a Sublicensee, AltaRex shall provide extracts from such
sublicense agreement to Biomira. Such extracts shall consist of the
following provisions of the sublicense agreement: (i) the identity of the
Sublicensee; (ii) the scope/field of the use of the Sublicensee under the
sublicense agreement; and (iii) the provisions required to be included in
the sublicense agreement pursuant to the following sections of this
Agreement (and any other provisions, such as defined terms, which may be
reasonably necessary to permit an understanding of such provisions):
Section 2.1, Section 2.4, Section 2.7, Section 3.5, Section 4.3 Section
4.5, Section 4.6, Article V, Section 6.1.1, Section 6.1.2 and a termination
provision similar to that set forth in Section 2.3. The provisions of the
sublicense agreement referred to in subsection (iii) are referred to as the
"Designated Sublicense Provisions".
(2) AltaRex agrees to ensure that the Designated Sublicense Provisions are
included in each sublicense agreement with a Sublicensee (whether granted
by AltaRex or a Sublicensee) and that such Designated Sublicense Provisions
will not be amended (except for an amendment which in no way derogates from
AltaRex's obligations under this Section 2.7) or deleted prior to the
termination of the sublicense in question. AltaRex shall use commercially
reasonable efforts to enforce or cause to be enforced the Designated
Sublicense Provisions against Sublicensees. AltaRex shall in a timely
manner keep Biomira informed as to any breaches by any Sublicensee of the
Designated Sublicense Provisions. In the event that Biomira believes that a
Sublicensee has breached any of the Designated Sublicense Provisions, it
may, in its discretion, provide notice of such claimed breach to AltaRex
and AltaRex shall, within fifteen (15) days after receipt of such notice,
use commercially reasonable efforts to cause the Sublicensee to comply with
the applicable Designated Sublicense Provisions and AltaRex shall take or
cause to be taken such other steps as may be commercially reasonable under
the circumstances, including the exercise of the termination remedies in
the applicable sublicense agreement with respect to a Sublicensee which has
breached any of the Designated Sublicense Provisions. In the event that
AltaRex fails to enforce or cause to be enforced the Designated Sublicense
Provisions against the relevant Sublicensees, despite having used
commercially reasonable efforts, Biomira shall have the right to seek an
injunction and/or bring an action(s) for damages and/or specific
performance against such Sublicensees and, in order to enable Biomira to
carry out the foregoing, AltaRex shall, as directed by Biomira, either
assign or cause to be assigned to Biomira in a timely manner any and all
actions or causes of action(s) relating to the claimed breach of the
Designated Sublicense Provisions or permit Biomira or cause Biomira to be
permitted to pursue such action(s) in the name of AltaRex or other
applicable party. In no event, however, shall the foregoing be construed to
permit or provide Biomira with the right to itself directly exercise the
termination remedies in the applicable sublicense agreement.
(3) Biomira and AltaRex agree that the obligations of AltaRex under this
Agreement in relation to sublicensing of any rights granted under this
Agreement (including without limitation the obligations with respect to the
Designated Sublicense Provisions and Biomira's rights under Section 2.7(2))
shall apply mutatis mutandis to any other transfer
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by assignment or otherwise of any rights or privileges granted by Biomira
under this Agreement.
ARTICLE III
COMMERCIALIZATION
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3.1 COMMERCIALIZATION
AltaRex agrees to use its best efforts to commercialize the Technology.
AltaRex may perform all or a portion of its obligations under this Section 3.1
through Sublicensees. Without limiting the generality of the foregoing, AltaRex
agrees to commit to spending at least $3,000,000.00 to develop the Technology
over the four year period immediately following the Effective Date of the
Original Agreement (subject to any unforeseen happening preventing the
commercialization of the Technology). The parties acknowledge that, as of the
date of execution of the Amended Agreement, AltaRex has spent in excess of
$3,000,000 on such development.
3.2 REPORTING
AltaRex shall keep Biomira advised as to the progress in the
commercialization and further development of the Technology, and the
development, manufacture, use and sale, either directly or through permitted
licensees or sublicensees, of any Licensed Products and shall provide a report
with respect thereto to Biomira at least annually. The form and content of such
report is set forth in EXHIBIT B to this Agreement.
3.3 GOVERNMENTAL AND REGULATORY APPROVAL
In the event that AltaRex requires for purposes of obtaining governmental
or regulatory approval for Licensed Products for Anti-Idiotype Applications
additional data or records of Biomira in the possession of Biomira beyond those
included as part of the Data, Biomira shall use all reasonable efforts to make
such required additional data and records available for such purposes on a
timely basis. Similarly, AltaRex shall provide similar assistance to Biomira in
connection with products developed by Biomira outside of Anti-Idiotype
Applications and in relation to the licenses granted to Biomira under Section
2.5
3.4 EFFECTIVE LACK OF DILIGENCE
(1) If Biomira reasonably believes that AltaRex is not meeting its diligence
obligations under Section 3.1 of this Agreement, then Biomira may provide
AltaRex with written notice of such deficiency. If within ninety (90) days
following receipt by AltaRex of such notice, Biomira has not been provided
with either (i) evidence satisfactory to Biomira acting reasonably that the
specified deficiency has been rectified, or (ii) a detailed plan of action
satisfactory to Biomira acting reasonably to commercialize the Technology
and overcome any problems hindering such commercialization, then AltaRex
shall have an additional sixty (60) days to provide a detailed plan of
action (an "Action Plan") satisfactory to Biomira acting reasonably. If
within such additional sixty (60) day period an Action Plan which is
satisfactory to Biomira acting reasonably is not presented to Biomira by
AltaRex, then Biomira shall have the rights set forth in Section 3.4 (b)
upon further
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written notice (the "Arbitration Notice") to AltaRex. If the Action Plan is
satisfactory to Biomira acting reasonably, then AltaRex shall use its
reasonable efforts, based on reasonable business consideration, to
implement such Action Plan. At any time after the expiry of one hundred
eighty (180) days following the acceptance of the Action Plan, Biomira may
serve notice to AltaRex that in the reasonable judgment of Biomira, actions
stipulated in such Action Plan have not been implemented. If within sixty
(60) days following such notice Biomira has not been reasonably satisfied
that AltaRex has taken actions called for in the Action Plan, Biomira shall
have the rights set forth in Section 3.4 (b) upon providing a further
written notice (the "Arbitration Notice") to AltaRex.
(2) Within fourteen (14) days after Biomira serves on AltaRex the Arbitration
Notice, AltaRex shall choose an arbitrator who together with the arbitrator
chosen by Biomira and named by Biomira in the Arbitration Notice will
choose a third arbitrator within seven (7) days of the appointment by
AltaRex of its arbitrator. The three arbitrators so appointed shall
constitute a panel which shall receive all relevant information from both
parties concerning AltaRex's compliance with its obligations of diligence
to commercialize under Section 3.1 and shall make a decision as to whether
or not AltaRex has fulfilled those obligations. The decision of the
arbitrators shall be made within sixty (60) days of appointment of the
third arbitrator and the decision of the arbitrators shall be final and
binding on both parties. If the decision of the arbitrators is that AltaRex
has not acted reasonably to commercialize the Technology as required under
Section 3.1, then Biomira shall have the right to serve AltaRex with a
notice which shall have the effect that the grant of rights under this
Agreement (including without limitation Section 2.1 hereof) will cease to
be exclusive. Biomira shall then have the right to grant one or more
licenses on nonexclusive terms to other parties for such rights.
(3) Copies of all notices provided by Biomira to AltaRex under this Section 3.4
shall be forwarded at the same time to the Designated Licensee, if any. The
implementation by such Designated Licensee of the Action Plan shall
constitute performance by AltaRex of its obligations under Section 3.1
3.5 COMPLIANCE WITH LAWS
AltaRex, on behalf of itself and its Affiliates, agrees to comply in all
material respects with any and all applicable local, state, provincial,
national, federal and/or international laws and regulations pertaining to the
development, testing, manufacture, promotion, sale and disposition of Licensed
Products and to mark all Licensed Products or their packaging with all
applicable patent numbers and similarly to indicate "patent pending" status and
to make such other markings as are necessary to preserve the Patent Rights.
AltaRex shall obtain the agreement of each Sublicensee to comply with the
provisions of this Section 3.5.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE IV
ROYALTY
-------
4.1 UP-FRONT FEE
AltaRex shall pay to Biomira on December 1, 1995 for the rights granted
under this Agreement and the delivery by Biomira to AltaRex of fifty vials of
the B43 Working Cell Bank an up-front payment of $150,000.00, which payment is
non-refundable and may not be credited against any other payments.
4.2 NET SALES REVENUE ROYALTY
4.2.1 AltaRex shall pay to Biomira in the manner provided in this Agreement,
during the Royalty Period, a royalty equal to [**]% of the Net Sales
Revenue.
4.2.2 In circumstances where AltaRex or any Sublicensee grants or otherwise
transfers to a Sublicensee any rights to the Technology or a particular
aspect thereof or grants a license to a Sublicensee to manufacture, market
or otherwise use the Technology or a particular aspect thereof or any
other rights granted by Biomira under this Agreement, AltaRex shall
continue to be obligated to pay to Biomira or cause to be paid to Biomira
the royalties referred to in section 4.2.1 of this Agreement.
4.3 REPORTS
Within sixty (60) days of June 30 and December 31 in each calendar year
following the First Commercial Sale of Licensed Products, AltaRex shall provide
to Biomira a written report, certified by a senior officer of AltaRex, showing
in reasonable detail and in such form as Biomira may reasonably request:
4.3.1 the Net Sales Revenue (including Net Sales Revenue by Sublicensees) during
the preceding six-month period;
4.3.2 the basis for the calculation of all royalties and other amounts payable
by AltaRex to Biomira pursuant to this Agreement; and
4.3.3 such other reasonable information with respect to the foregoing as Biomira
may request.
4.4 REMITTANCE
With each report referred to in Section 4.3 of this Agreement, AltaRex
shall remit to Biomira the total amount of royalties then due to Biomira under
this Agreement. All payments under this Agreement shall be made in lawful funds
of Canada at the address provided for Biomira in Section 7.7 of this Agreement,
or at such other place as Biomira may reasonably request in writing. AltaRex
shall pay interest on any overdue royalty or other payment to be made pursuant
to this Agreement at the variable annual rate of interest announced and adjusted
from time to time by the Canadian Imperial Bank of Commerce ("CIBC") as its
reference rate then in effect for determining interest rates on commercial loans
in Canadian dollars made by the CIBC in Canada ("CIBC Prime") commencing on the
date that such payment is due up to the date that such payment is paid in full.
For the purposes of computing amounts due to Biomira
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where AltaRex receives payment in a currency other than Canadian dollars, the
amount so received shall be converted to Canadian dollars at the conversion rate
published on the date of receipt of the payment in The Globe & Mail newspaper.
4.5 RECORDS
AltaRex shall maintain adequate and complete records (and shall require
its Sublicensees to maintain such records) showing:
4.5.1 the Net Sales Revenue received by AltaRex or any Sublicensees; and
4.5.2 the basis for the calculation of all royalties and other amounts payable
by AltaRex to Biomira pursuant to this Agreement.
AltaRex shall retain such records (and shall require each Sublicensee to retain
such records) for a period of five (5) years from the date of their making.
4.6 AUDIT INSPECTION
(1) AltaRex and its Affiliates shall make available the records referred to in
Section 4.5 for the prior five (5) year period on reasonable notice during
AltaRex's normal business hours for inspection by a national firm of
chartered accountants or certified public accountants on behalf of Biomira
PROVIDED HOWEVER no one will be allowed to inspect any records of AltaRex
and its Affiliates without having first signed a confidentiality agreement
provided by AltaRex which shall contain only terms which are consistent
with industry standards in similar circumstances and which will not
restrict the accountants in question from pursuing the inspection rights
hereunder and reporting to Biomira. Any such inspection shall be made at
the expense of Biomira unless it is determined that Biomira was entitled
to receive a sum which varied greater than ten (10%) percent from the
amount reported by AltaRex as due and payable to Biomira for the period
covered by the inspection, in which case AltaRex shall pay the reasonable
costs of such inspection and interest, as provided in Section 4.4. AltaRex
and its Affiliates shall cooperate fully with the chartered accountants or
certified public accountants conducting the inspection provided for in
this Section 4.6.
(2) In the event that AltaRex conducts an audit of the records and books of
account of a Sublicensee, the audit report shall be provided to Biomira by
the chartered accountant or certified public accountant at the same time
that such report is provided to AltaRex. In addition, in the event that
Biomira believes that it would be appropriate to conduct an audit of the
records and books of account of a Sublicensee (other than an Affiliate of
AltaRex), Biomira shall notify AltaRex and AltaRex shall promptly use
commercially reasonable efforts to cause such audit to be conducted, with
the audit report to be provided simultaneously to AltaRex and Biomira.
AltaRex shall obtain the written agreement of each Sublicensee to permit
the conduct of such audits and the provision of the audit report to
Biomira. Biomira agrees to treat each such audit report as Confidential
Information of AltaRex.
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4.7 OVERPAYMENT BY ALTAREX
If the amount of royalties payable by AltaRex as indicated by the
inspection described in Section 4.6 of this Agreement is less than the amount
which has been paid by AltaRex to Biomira in respect of a particular period,
Biomira shall refund to AltaRex the amount of the difference, together with
interest at a rate per annum equal to CIBC Prime on such amount commencing on
the date upon which such amount was due under this Agreement up to the date upon
which such amount is paid in full, within 10 days after receipt of the results
of such inspection.
4.8 UNDERPAYMENT BY ALTAREX
If the amount of royalties payable by AltaRex as indicated by inspection
described in Section 4.6 of this Agreement is greater than the amount which has
been paid by AltaRex to Biomira in respect of a particular period, AltaRex shall
pay to Biomira the amount of the difference, plus interest at a rate per annum
equal to CIBC Prime on such amount commencing on the date upon which such amount
was due under this Agreement up to the date upon which such amount is paid in
full, within ten (10) days after receipt of the results of such inspection.
ARTICLE V
CONFIDENTIALITY
---------------
5.1 CONFIDENTIALITY
5.1.1 Subject to Section 5.2 of this Agreement, all Confidential Information
shall be held in strict confidence by each of the parties to this
Agreement and each party to this Agreement shall employ or cause to be
employed diligent efforts and reasonable care in order to ensure that such
Confidential Information is not made available to any third party
excepting only as required under this Agreement, or to the directors,
officers, employees and consultants of such party to this Agreement whose
duties require disclosure of the same and then (in any such case) only if
the parties to whom such Confidential Information is being disclosed have
given to each of the parties to this Agreement an enforceable undertaking
(in form acceptable to Biomira and AltaRex, acting reasonably) not to
disclose such Confidential Information to any other party, PROVIDED THAT
AltaRex may disclose Confidential Information -------- ---- to a
Sublicensee so long as such Sublicensee has agreed to treat the
Confidential Information in the manner provided in this Article V.
5.1.2 Subject to Section 5.1.3 of this Agreement, Confidential Information which
is obtained by any party to this Agreement from a third party without
obligation of confidence (provided, however, that such third party has no
obligation of confidence to one of the parties hereto) or which becomes
public knowledge otherwise than through the fault of a party to this
Agreement or any of such party's directors, officers, agents, consultants,
servants or employees, shall be deemed to be in the public domain and
accordingly Section 5.1.1 of this Agreement shall not apply to such
portion of the Confidential Information which has been so obtained or
which has become public knowledge.
5.1.3 Confidential Information which is specific shall not be deemed to be
within the public domain merely because it is embraced by general
knowledge in the public domain.
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Further, any Confidential Information dealing with any combination of
features of a specific matter shall not be deemed to be within the public
domain, unless the combination of features and the principle of operation
are in the public domain.
5.1.4 Each party to this Agreement shall, upon the termination of this
Agreement, return all corporeal Confidential Information to the owner of
such Confidential Information with a written undertaking that no copies,
duplicates or progeny have been retained.
5.1.5 Each of the parties of this Agreement acknowledges that the other parties
to this Agreement would suffer irreparable harm as a result of the breach
of any of the non-disclosure and confidentiality obligations set forth in
this Article 5 and that legal remedies are inadequate; therefore, each of
the parties to this Agreement agrees that, in addition to any damages and
other remedies that the other parties to this Agreement may be entitled to
as a result of such a breach, the other parties to this Agreement shall be
entitled to an order from a court of competent jurisdiction restraining
such party from breaching or continuing to breach any of the provisions of
this Article 5.
5.1.6 The covenants of the parties under this Article 5 shall continue in full
force and effective notwithstanding the termination of this Agreement by
effluxion of time or otherwise.
5.1.7 In the event either party is required by law or any governmental or
regulatory authority having jurisdiction to disclose any information that
party has the right to do so subject to such party hereto using its best
efforts to take all reasonably available means to keep details of this
Agreement and its terms and the Confidential Information of the other
party confidential.
5.1.8 Nothing in this Agreement shall prevent AltaRex through its officers,
employees or agents from presenting or publishing such information related
to the Technology as is necessary for the commercialization of Licensed
Products, including, but not limited to, the use of the Technology in
patent applications and patents, communications with regulatory
authorities, scientific publications and presentations and marketing
materials; PROVIDED THAT AltaRex shall ensure that in doing so, no Biomira
Confidential Information other than Biomira Confidential Information
relating to the Technology will be disclosed without Biomira's prior
written consent which may be unreasonably withheld.
ARTICLE VI
DISCLAIMER AND INDEMNIFICATION
------------------------------
6.1 "AS IS" BASIS
6.1.1 AltaRex has agreed to acquire the rights granted under this Agreement, and
all of the data and other materials acquired hereunder on an "as is"
basis. AltaRex shall, and shall require each Sublicensee to, include a
provision in each agreement with a Sublicensee acknowledging the prior
sentence. Accordingly, AltaRex shall accept the entire responsibility
related to or arising out of the use by AltaRex or any Sublicensee of the
Technology or the development, manufacture, use or sale of any product
based on the
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Technology. Except as set forth in Section 2.3, Biomira makes no
warranties, whether expressed or implied, as to any matter whatsoever to
AltaRex or any third parties with respect to the Technology, any Licensed
Product or any aspect thereof, including without limitation, as to the
validity of any right granted by Biomira under this Agreement or that any
such right or Licensed Product will be free from infringement of the
rights of third parties. If AltaRex or any Sublicensee receives written
notice that any Licensed Product or right granted under this Agreement
constitutes an infringement of the rights of a third party, AltaRex shall,
if it or any Sublicensee intends to continue to develop, manufacture, use
or sell such Licensed Product, within fifteen (15) days after receipt of
such notice, provide to Biomira a means reasonably satisfactory to
Biomira, whereby Biomira shall be fully protected from damages, actions,
claims, costs and expenses which may arise as a result of the decision of
AltaRex or any Sublicensee to continue to develop, manufacture, use or
sell the Licensed Product or to use such right. If, after complying with
the preceding sentence, AltaRex or any Sublicensee continues to develop,
manufacture, use or sell the Licensed Product or use such right, AltaRex
or such Sublicensee does so at its own risk and AltaRex will and does
hereby indemnify Biomira for any damages, actions, claims, costs and
expenses incurred by Biomira, except as provided in Section 2.3, which may
arise as a result of AltaRex, its Affiliates or Sublicensees continuing to
develop, manufacture, use or sell the Licensed Product or use such right.
6.1.2 AltaRex, on behalf of itself and its Affiliates, acknowledges that the
Technology is the property of Biomira and that Biomira has made no
representations or warranties to AltaRex in connection with the Technology
under this Agreement and AltaRex hereby agrees that it will not make any
claim or demand against Biomira or any of its officers, directors,
employees, agents or consultants for any loss, cost, damage or expense,
whether direct or indirect or consequential, suffered or sustained by
AltaRex or any person claiming through AltaRex, which is based upon,
arises out of or is connected with the Technology and AltaRex hereby
waives as against Biomira, its officers, directors, employees, agents and
consultants all such claims and demands. In any agreement with a
Sublicensee, AltaRex shall secure or cause to be secured a similar
covenant from such Sublicensee.
6.2 INDEMNIFICATION BY ALTAREX
AltaRex agrees to indemnify and save harmless Biomira, its officers,
directors, employees, agents and consultants:
6.2.1 from and against any and all actions, causes of action, claims, demands,
awards and proceedings of every nature and kind whatsoever and by
whosoever made, brought or prosecuted; and
6.2.2 from and against any and all loss, damage, cost or expense suffered or
incurred by Biomira, its officers, directors, employees, agents or
consultants,
which are based upon, arise out of or are connected with the acts of AltaRex,
its employees, agents, consultants and contractors and the Affiliates of AltaRex
and the Sublicensees under this Agreement or in connection with their
development, manufacture, sale or other use of the
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Technology or any product based on the Technology or the rights granted by
Biomira under this Agreement.
6.3 INDEMNIFICATION BY BIOMIRA
Biomira agrees to indemnify and save harmless AltaRex, its officers,
directors, employees, agents and consultants from and against any and all
actions, causes of action, claims, demands, awards and proceedings of every
nature and kind whatsoever and by whosoever made, brought or prosecuted, and
from and against any and all loss, damage, cost or expense suffered or incurred
by AltaRex, its officers, directors, employees, agents or consultants, which are
based upon, arise out of or are connected with the acts of Biomira, its
employees, agents, consultants, contractors and Affiliates in connection with
their development, manufacture, sale or other use of (a) the Multi-Epitopic
Patent Rights, or (b) any products based on the Multi-Epitopic Patent Rights.
6.4 INSURANCE
AltaRex shall procure and maintain product liability insurance providing
such coverage as is customarily obtained by similarly-sized biopharmaceutical
companies in the United States having products in the same stage of development
or commercialization as AltaRex.
ARTICLE VII
MISCELLANEOUS PROVISIONS
------------------------
7.1 TIME OF THE ESSENCE
Time shall be of the essence of this Agreement.
7.2 FURTHER ACTS
Each of the parties to this Agreement shall at the request of any other
party, execute and deliver any further documents and do all acts and things as
that party may reasonably require in order to carry out the true intent and
meaning of this Agreement.
7.3 NO PARTNERSHIP
Nothing in this Agreement or in the relationship of the parties hereto
shall be construed as in any sense creating an agency, joint venture, employer
and employee or partnership relationship among the parties or as giving to any
party any of the rights or subjecting any party to any of the creditors of the
other parties.
7.4 PARTIES OF INTEREST
This Agreement shall enure to the benefit of and be binding upon the
parties hereto, their permitted assigns and their personal representatives,
administrators, heirs and successors.
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7.5 GOVERNING LAW AND ATTORNMENT
This Agreement shall be governed by the laws of the Province of Alberta
(including for greater certainty, the laws of Canada applicable in the Province
of Alberta) and the parties hereto agree to irrevocably attorn to the
non-exclusive jurisdiction of the courts of Alberta.
7.6 ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between the parties to
this Agreement with respect to the subject matter of this Agreement and
supersedes all prior negotiations, proposals and agreements, whether oral or
written, with respect to the subject matter of this Agreement.
7.7 NOTICES
Any notice required to be given under the terms hereof shall be given by
any party hereto by delivering such notice to the party to which it is to be
given at the address below or at such other existing municipal address as any
party may provide in written to the other parties in lieu thereof in accordance
with this Section 7.7 or by sending such notice by means of recorded
telecommunications to the party to which it is to be given at the fax number
below or at such other fax number as any party may provide in writing to the
other parties in lieu thereof in accordance with this Section 7.7:
In the case of Biomira: Biomira Inc.
2011 - 94 Street
Edmonton, Alberta T6N 1H1
Attention: President
Fax No.: (780) 450-4772
With a copy to: Fraser Milner
#2900, 10180 - 101 Street
Edmonton, Alberta T5J 3V5
Attention: Michael D. Obert
Fax No.: (780) 423-7276
In the case of AltaRex: AltaRex Corp.
303 Wyman Street
Waltham, MA 02451
Attention: Richard E. Bagley
Fax No.: (781) 466-8740
With a copy to: Hale and Dorr LLP
60 State Street
Boston, MA 02109
Attention: Steven D. Singer, Esq.
Fax No.: (617) 526-5000
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Any such notice shall be deemed to have been received by a party hereto
immediately upon delivery to, in the case of an individual, such party at its
address in such notice and, in the case of a corporation, upon delivery to any
director or officer of such party at its address in such notice or on the first
business day in the place where the recorded telecommunication is to be received
following the day of sending.
7.8 CANADIAN DOLLARS
Any reference in this Agreement to dollars shall be to Canadian dollars.
7.9 BUSINESS DAY
Any obligations required to be performed by a party under this Agreement
on a day, other than a day upon which the Canadian chartered banks are open for
business in Edmonton, Alberta, shall be properly discharged if performed by such
party on the next following day upon which such banks are open for business in
Edmonton, Alberta.
7.10 WAIVER
Failure by any party hereto to insist in any one or more instances upon
the strict performance of any one of the covenants contained herein shall not be
construed as a waiver or relinquishment of such covenant. No waiver by any party
hereto of any such covenant shall be deemed to have been made unless expressed
in writing and signed by the waiving party.
7.11 SEVERABILITY AND RENEGOTIATION
The unlawfulness or invalidity or unenforceability of any provision in
this Agreement or of any covenant herein contained on the part of any party
shall not affect the validity or enforceability of any other provision or
covenant hereof or herein contained and the parties hereby undertake to
renegotiate in good faith, with a view to concluding arrangements as nearly as
possible the same as those herein contained.
7.12 AMENDMENTS
No term or provision hereof may be amended except by an instrument in
writing signed by all of the parties to this Agreement.
7.13 ASSIGNMENT
Biomira acknowledges herein that AltaRex in developing Licensed Products,
may need to enter into arrangements with third parties pursuant to which certain
of the rights of AltaRex under this Agreement will be sublicensed or assigned
and AltaRex shall be entitled to make such sublicenses and assignments without
Biomira's consent or approval, subject to complying fully with the terms and
conditions of this Agreement with respect thereto. Notwithstanding any
assignment by AltaRex of its rights under this Agreement, AltaRex shall continue
to remain liable for all of its obligations under this Agreement in the event
that the assignee fails to perform such obligations in the manner required
pursuant to this Agreement.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
7.14 TAXES
In the event that a party obligated to make a payment under this Agreement
ceases to be a Canadian resident and as a result there is a withholding or other
deduction required to be made with respect to such payment, then such party
shall be responsible for any such withholding or other deduction and no
reduction shall be made in the amount of such payment.
7.15 COUNTERPARTS
This Agreement may be executed in several counterparts, each of which when
so executed shall be deemed to be an original and shall have the same force and
effect as an original but such counterparts together shall constitute but one
and the same instrument.
7.16 SURVIVAL
Notwithstanding any termination of this Agreement, the following
provisions shall survive such termination and shall remain in full force and
effect: Section 2.5, Article IV, Article V, Article VI and Article VII.
7.17 STEP-DOWN
If for any reason the definition of "Royalty Period" set forth in Section
1.1(21) is held unenforceable by a court of competent jurisdiction in an
unappealled or unappealable decision, then such Royalty Period shall become the
period commencing on the January 1 following the First Commercial Sale of a
Licensed Product in such country and ending [**] years later.
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ARTICLE VIII
EXECUTION
---------
8.1 EXECUTION
This Amended Agreement has been executed by Biomira and AltaRex as of the
3rd day of September, 1999.
BIOMIRA INC.
Per: /s/ Edward A. Taylor
--------------------------------------
Edward A. Taylor
V.P. Finance & Admin. & CFO
ALTAREX CORP.
Per: : /s/ Richard E. Bagley
------------------------------------
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EXHIBIT A
PROPRIETARY RIGHTS
1. Selective Alteration of Antibody Immunogenicity (copy of filing receipt
attached)
2. Photoactivation of Proteins for Conjugation Purposes (copy of filing
receipt attached)
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EXHIBIT B
The form of written report to be provided by AltaRex pursuant to Section
3.2 of the License Agreement is intended to provide a description of the
activities of AltaRex and Sublicensees during the period covered by the report
related to the Technology in sufficient detail to enable a reasonable
understanding of the applicable matters. Each report shall, to the extent
applicable, include the following:
1. description of the research, development and clinical progress and plans;
2. status of applications for regulatory approvals;
3. status of manufacturing, sublicensing and marketing activities;
4. description of the projected activities to be undertaken during the next
reporting period and a comparison of the actual activities versus the
previously projected activities for the prior reporting period;
5. list and status of patent applications included in the Multi-Epitopic
Patent Rights;
6. financial information from publicly available sources (e.g. reports filed
with Canadian and U.S. securities regulators); and
7. such other information pertinent to the development and commercialization
of the Technology as the Parties may agree upon from time to time or which
would be necessary for a reasonable third party to achieve an understanding
under the circumstances of the activities of AltaRex and Sublicensees
relating to the Technology.
The Parties agree that the Chief Executive Officers of AltaRex and Biomira
shall engage in an annual dialogue concerning the form and content of the
reports provided pursuant to Section 3.2 of the Agreement.
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